← FDA Medical Device Classifications

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RBI · Not classified · Unknown

Classification

FDA Product Code
RBI
Device class
Not classified
Regulation
Review panel
Medical specialty
Unknown
Submission type
GMP exempt
Y
Life sustaining
Implant
Third-party review

Definition

An electronic product using a cathode ray tube to display the image seen through the lens of a camcorder. To be exempt the cathode ray tube must operate under 5 kilovolts under the test conditions in the standard (phase iii).

Market data

Cleared 510(k) submissions
0
Registered establishments
0

Source

Authoritative
FDA Device Classification database
Machine
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